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About

Delta Synthetic was founded in 1961. The mission of Delta is production of highest quality active pharmaceutical ingredients.

Delta Synthetic Co., Ltd. has filed Drug Master Files (eCTD format) for its facility and major products. The production facility is inspected regularly by US FDA and TFDA (PIC/S member).

Final dosage forms made with Delta's bulk products are widely distributed in the United States, Europe, Asia and Oceania.

Quality and Research

Not only is Delta Synthetic a specialized API manufacturer of its current products, but Delta also devotes its expertise and resources in to research and development.

Main Products

Items Products Functions Specifications
1

Guaifenesin
甘油癒創木醚

Expectorant
袪痰
USP43, BP2020, EP10, JP17
2

Lidocaine
利度卡因

Local Anesthetic
局部麻醉
USP43, JP17, BP2020, EP10
3

Lidocaine HCl
鹽酸利度卡因

Local Anesthetic
局部麻醉
USP43, BP2020, EP10

Company History

立大化成工業股份有限公司的前身是 立大化學製藥股份有限公司。成立於1961年,位於板橋市信義路16號。當時以製劑為主,製造錠劑、膠囊劑、口服劑、軟膏類、及省內特殊合成藥品原料。

為擴展藥品原料之生產,於1980年成立立大化成工業股份有限公司,覓地新北市 土城區民生街15號現址建廠,開始專業化學合成製造藥品原料。  

產品接受美國FDA之查廠合格,暢銷美國及歐洲等國家。

1985年9月7日,美國 FDA指定給立大化成工業股份有限公司標誌代碼60203。

CODES

1985/4/11,US FDA指定給立大化成工業股份有限公司的產品Guaifenesin Type II DMF 代碼005809。

1995/2/10,US FDA指定給立大化成工業股份有限公司的產品Lidocaine HCl Type II DMF 代碼011338。

1995/4/11,US FDA指定給立大化成工業股份有限公司的產品Lidocaine Type II DMF 代碼 011339。

EDQM Guaifenesin: Certificate of suitability No. R1-CEP 2009-351-Rev 02

EDQM Lidocaine: Certificate of suitability No. R1-CEP 2010-320-Rev 01

EDQM Lidocaine HCl: Certificate of suitability No. R1-CEP 2013-198-Rev 00

D-U-N-S Number: 656128618

Delta Synthetic Co., Ltd.

15, Minsheng St., Tucheng Dist., New Taipei City 23679, Taiwan (R.O.C.)
Tel: 886-2-22685604
Fax:886-2-22680895
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